Subject: California

§ 510(k) Safety and Effectiveness – A Changing Landscape for Punitive Damages?

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The Central District of California recently issued an opinion that breathes new life into the argument that the § 510(k) substantial equivalence process for Class II medical devices involves an FDA finding of safety and effectiveness. It is part of a trend of recent federal cases giving credence to the § 510(k) process, which could have significant implications for punitive damages claims brought against manufacturers of Class II devices.

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The California Supreme Court Addresses the Admissibility of Industry Custom and Practice Evidence In a Design Defect Case and Holds That … It Depends

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In Kim v. Toyota Motor Corp., No. S232754 (August 27, 2018) the California Supreme Court broke with 40+ years of intermediate court of appeal precedents barring manufacturers from using evidence of their compliance with industry custom and practice to prove their design was not defective.  Rather, the Court held, such evidence is no longer categorically inadmissible, but neither is it categorically admissible.  Admissibility depends on the nature of the evidence and the purpose for which it is offered.

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Uncertain Expectations – California’s Long Struggle with How to Measure Defectiveness in a Product’s Design (Part 3)

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Recap:  Part 1 (here) discussed the background of the consumer expectations test (CET) and part 2 (here) described the California Supreme Court’s seemingly definitive decision in Soule v. General Motors Corp., 8 Cal.4th 548 (1994) explaining the types of cases where CET can be applied.

Any expectation by legal consumers that Soule’s careful guidance would produce coherence and consistency was overly optimistic. The courts’ conceptual struggles in the wake of Soule are best illustrated by a string of decisions in cases that, like Soule, deal with “crashworthiness” or “enhanced injury.” These cases allege that the vehicle failed to adequately protect the occupant in a crash.

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To Toll or Not to Toll? An Unsettling Answer

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Resolving a split among the intermediate appellate courts, the California Supreme Court recently issued an opinion that dramatically extends the period to file suit for birth defects in toxic tort cases. In Lopez v. Sony Electronics, Inc., No. S235357 (Cal. 7/5/18), the court held that these cases, already subject to tolling under the delayed discovery rule, are also tolled during the period of the plaintiff’s minority. The limitations clock does not even start to tick until at least the plaintiff’s eighteenth birthday.

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Uncertain Expectations – California’s Long Struggle with How to Measure Defectiveness in a Product’s Design (Part 2)

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Recap:  The background and prior post for this multi-part series can be found here.

In 1994, the California Supreme Court took up Soule v. General Motors Corp., 8 Cal.4th 548 (1994), to provide much-needed guidance as to when it is and is not appropriate to allow a jury to decide the design defect issue based on the consumer expectations test (CET). “Much-needed” may be an understatement – trial courts routinely allowed plaintiffs freely to elect what design defect standard the jury would consider, often both CET and the risk-benefit test (RBT), gaining the proverbial two bites at the apple, and the courts of appeal had not prescribed any meaningful limiting theory or principle.

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Uncertain Expectations – California’s Long Struggle with How to Measure Defectiveness in a Product’s Design

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In the 50-plus years since the inception of the doctrine of strict products liability in tort, a vexing issue for product manufacturers has been how to evaluate and defend against accusations of design defect. Manufacturing defects are relatively easy to evaluate – something either did or did not go wrong on the assembly line, the product either did or did not conform to specifications. But except for the rare and extreme cases where, in hindsight, the design is so clearly misguided that no reasonable engineer would consider it safe, courts, commentators and lawyers have hotly debated the proper benchmark to judge the alleged defectiveness of an entire product line.

Manufacturers like to know what to expect. Without a concrete liability standard, they cannot confidently design their products to satisfy it, and they cannot rationally evaluate their liability exposure when they get sued. Even better for manufacturers would be a standard that actually makes sense, and is reasonably attainable.

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